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Completed

NCT Number: NCT06170385

Pediatric Early Rehabilitation in Acute Lymphoblastic Leukemia

The purpose of this study is to determine the feasibility and acceptability of a hybrid in-person and virtual individualized physiotherapy program using the Healthy Eating and Active Living (HEAL-ME) online platform for children diagnosed with acute lymphoblastic leukemia. We would like to know if this type of hybrid program delivery model is feasible, and if children and their parents are willing and able to participate in the program. We will do this by recording how many, and what type of physiotherapy sessions (in-person or virtual) are completed, what resources offered on the platform are accessed, and how many children complete the assessments.

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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G2R3, Canada

About this study

Acute lymphoblastic leukemia is the most common childhood cancer, representing approximately 25% of cancers in children. Improvements in survival rates have resulted in an increased number of children living with neuromuscular and musculoskeletal side effects of cancer treatments-effects that may persist or worsen over the long-term into adulthood.

The overall goal of the study is to determine the feasibility of a tailored physiotherapy (PT) program using an online platform for children diagnosed with acute lymphoblastic leukemia.

A quasi-experimental, single group, before and after intervention feasibility study will be conducted, comprising a convenience sample of a minimum of 10 children between 4 and 17 years of age undergoing or having completed chemotherapy treatment for acute lymphoblastic leukemia. Children will participate in a hybrid 12-week PT program delivered in-person at the Stollery Children's Hospital with educational components provided virtually via the Healthy Eating and Active Living web-based platform. Children will participate in six physical therapy sessions over a period of three months and will have the option to choose the mode of delivery: 1:1 in-person, 1:1 virtual, group virtual, or combination of all. The main outcome will be feasibility, as determined by recruitment and retention rates, completion rates of measurements, adherence to sessions, and safety and acceptability.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children diagnosed with acute lymphoblastic leukemia aged between 4 and 17 years (at time of diagnosis) and their mother, father, or primary carer;
  • Undergoing or completed cancer treatment as established by the Children's Oncology Group;
  • Access to the internet through a home computer or tablet;
  • Patient or caregiver is able to speak and comprehend English; and
  • The child is approved by their Oncologist to participate in the program.

Exclusion criteria

  • Children with a history of a neurodevelopmental or genetic disorder (i.e., Down syndrome, autism, seizure disorder) prior to the cancer diagnosis; and
  • Children with a concurrent condition (illness, disease, psychiatric disorder), as determined by oncologist or physiotherapist, that would compromise study participation or interpretation of study results.

Treatment and study plan

Physical Therapy

Behavioral

Each physical therapy session will commence with a 5-minute warm-up, with fun activities to mobilize the joints and activate the muscles, using the videos available in the HEAL-ME platform. The warm-up session will be followed by a 20 to 40-min program with tailored activities and games comprising jumping, squatting, skipping, balancing, and jogging. The session will finish with a 5-minute cool down with stretching exercises and a relaxation video from the HEAL-ME platform.

Primary outcomes

  1. Retention rate

    Time frame: Post-intervention: 12 weeks

    The number of participants completing the intervention and assessments

Secondary outcomes

  1. Recruitment rate

    Time frame: One year

    Number eligible divided by the number of participants enrolling in the study

  2. Adherence to study intervention

    Time frame: Post-intervention: 12 weeks

    Attendance rates for in-person and virtual physical therapy sessions

  3. Adverse events

    Time frame: One year

    Number of serious and non-serious adverse events

  4. Acceptability

    Time frame: Post-intervention: 12 weeks

    Satisfaction survey

  5. Health-related Quality of Life

    Time frame: Post-intervention: 12 weeks

    Pediatric Quality of Life Inventory Version 4: Total scale score, with higher scores reflecting better quality of life

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Health services

Registry information

Official study title

Pediatric Early Rehabilitation in ACute Lymphoblastic LEukemia (PEACE): A Feasibility Study of a Hybrid Delivery Format

Acronym: PEACE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 14, 2023
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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